Laser Induced Changes to Innervation and Vascularisation of Psoriatic Skin

NCT05079256 | Completed FDA Device

• 1 other identifier: LPA-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers investigate the effect of a treatment with selective photothermolysis using a 595 nm pulsed dye laser on the blood vessel density and the nerve fibre density of a psoriatic lesion. By comparing tissue samples collected before and after two treatments, the researchers determine the relative effect of laser therapy on the (hyper)innervation of psoriatic skin.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Recovery ration

  Relative change in the ratio of the linear nerve density and linear blood vessel density.

  6 months.

Secondary Outcomes (2)

• Recovery ratio vs lymphocyte infiltration

  6 months

• Clinical improvement

  6 months

Study Arms (1)

Laser therapy

EXPERIMENTAL

595 nm Pulsed dye laser (PDL) therapy for psoriasis

Device: 595 nm Pulsed dye laser (Candela V-beam perfecta)

Interventions

595 nm Pulsed dye laser (Candela V-beam perfecta) DEVICE

595 nm pulsed dye laser therapy. 2 treatments Fluence \~ 6 - 9 J/cm\^2 Pulse duration \~ 0.45 - 3.0 ms 33% overlap.

Laser therapy

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Psoriasis vulgaris
• Skin type I - III
• Minimal surface of lesion of 3 cm2
• Contralateral psoriasis vulgaris lesions located on chest, back, or upper legs

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study if:
• The participant uses other treatments (than laser therapy) during the study or two weeks before the start of the study that are known to affect psoriasis
• The participant suffers from any known neurological, vascular, or immunological condition other than psoriasis.
• The participant is allergic to lidocaine

Sponsors & Collaborators

• Nick van der Beek: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (1)

ZBC MultiCare

Hilversum, North Holland, 1217AB, Netherlands

Location

Related Links

• This investigation is part of a larger research collaboration, more information on which can be found at the website mentioned above.

MeSH Terms

Interventions

Lasers, Dye

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Nick van der Beek, Ph.D

  ZBC MultiCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: tissue samples are described using random pre-assigned codes.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Managing director

Model Details: single blinded intra-patient comparison

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 15, 2021
• Study Start: December 9, 2022
• Primary Completion: October 12, 2024
• Study Completion: October 12, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)